TB-TST (TB treatment support tools): Refinement and evaluation of an interactive mobile app and direct adherence monitoring on TB treatment outcomes

TB-TST（结核病治疗支持工具）：交互式移动应用程序的改进和评估以及结核病治疗结果的直接依从性监测

• 批准号: 10636628
• 负责人: Sarah Jo Hannah Iribarren
• 金额: $ 37.69万
• 依托单位: INSTITUTO DE EFECTIVIDAD CLINICA Y SANIT
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-06-19 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10636628
• 关键词: Address; Adherence; Anxiety; Argentina; Biomedical Engineering; Caring; Case Management; Cause of Death; Cessation of life; Collaborations; Communicable Diseases; Communication; Communities; Disease; Disease Management; Education; Enrollment; Ethics; Evaluation; Face; Family; Feedback; Focus Groups; Friends; Future; Goals; Home; Image; Incidence; Individual; Institution; Intervention; Investigation; Learning; Link; Measures; Medical Care Team; Methods; Monitor; Multidrug-Resistant Tuberculosis; Newly Diagnosed; Outcome; Paper; Patient Monitoring; Patient Self-Report; Patient-Focused Outcomes; Patients; Perception; Persons; Pharmaceutical Preparations; Pilot Projects; Policy Maker; Positioning Attribute; Proliferating; Provider; Public Health; Randomized; Reaction Time; Regimen; Reporting; Research; Self Administration; Self Management; Stigmatization; Supervision; Technology; Testing; Treatment Protocols; Treatment Side Effects; Treatment outcome; Tuberculosis; Urine; Visualization; Work; World Health Organization; arm; barrier to care; cost; diaries; drug resistance development; experience; global health; global health emergency; implementation barriers; improved; innovation; interest; isoniazid; iterative design; mHealth; medication compliance; mobile application; mobile computing; patient retention; patient-clinician communication; personalized medicine; pilot test; preventable death; primary outcome; randomized, clinical trials; secondary outcome; self testing; sensor; side effect; social stigma; success; support tools; technology platform; test strip; tool; treatment adherence; treatment as usual; tuberculosis treatment; usability; user centered design

PROJECT SUMMARY The overall goal of this study is to refine the tuberculosis (TB) treatment support tools (TB-TST) intervention, which links an app developed using user-centered design principles and a paper-based drug metabolite urine test strip modified for home use, to improve treatment outcomes for patients with TB, and evaluate its impact by a RCT. TB is an urgent global health threat and the world's deadliest infectious disease despite it being largely curable. Poor medication adherence to TB regimens, along with challenges in monitoring patients and returning them to treatment, are important contributing factors to poor outcomes and the development of drug resistance. Individuals with TB face multiple barriers to good treatment adherence such as medication side effects, stigma, and lack of education about the disease and its treatment. With advances in, and proliferation of, mobile technology platforms, there is substantial interest in the possible use of mobile health (mHealth) interventions to address these challenges. Of the mHealth approaches under investigation for TB adherence monitoring, drug metabolite testing has been identified as the most promising, ethical, and accurate, and the least intrusive and stigmatizing strategy compared to other mobile solutions (eg, video observation, “smart” medication bottles, ingestible sensor), yet its potential remains largely unexplored. Additionally, mobile applications (apps) may provide personalized treatment supervision, increase patients' self-management and improve patient-provider communication by offering more advanced functionalities for patient support and monitoring. However, available TB-related apps have not focused on patients as the end- users nor have they been fully evaluated. This proposal builds on preliminary work to 1) combine input from patients and experts to iteratively design the content, features, functionalities, and interface of the treatment support app and 2) optimize a paper-based test strip for testing the presence of isoniazid drug metabolites in urine to directly monitor adherence to treatment. The existing version of the TB-TST app has the following functionalities: it offers education on TB and its treatment, communication with a care-coordinator, tracks treatment adherence (both by self-reporting and direct metabolite test strip images), self-reports treatment side-effects, and retains patient's “diary” notes. The results from the pilot test of this version will be the starting point for this proposed study. Aims are to: 1) Refine the TB-TST intervention based on pilot study findings and apply principles of user-centered design; 2) Evaluate the impact of the TB-TST on treatment outcomes (success, default) compared to usual care; 3) Assess patient and provider perceptions of the facilitators and barriers to implementation of the TB-TST and synthesize lessons learned with stakeholders and policy makers. The primary outcome will be treatment success. Secondary outcomes will include: treatment default rates, self-reported adherence, technology use and usability. Findings have broader implications not only for TB adherence but disease management more generally and will improve our understanding of how to support patients facing challenging treatment regimens.

项目摘要 这项研究的总体目标是完善结核病（TB）治疗支持工具（TB-TST）干预措施，该工具将使用的应用程序链接 以用户为中心的设计原理和一个基于纸张的药物代谢物尿液测试条修饰用于家庭使用，以改善治疗结果 结核病患者，并通过RCT评估其影响。结核病是全球紧急的全球健康威胁，也是世界上最致命的传染病目的地 在很大程度上可以治愈。对TB方案的药物依从性不佳，以及监测患者并将其返回治疗方面的挑战， 是导致不良结果和耐药性发展的重要因素。有TB的人面临多个良好的障碍 治疗依从性，例如药物副作用，污名以及对疾病及其治疗的缺乏教育。随着进步和 移动技术平台的扩散，可能使用移动健康（MHealth）干预措施来解决 这些挑战。在调查TB依从性监测的MHealth方法中，药物代谢物测试已被确定为 与其他移动解决方案相比 观察到“智能”用药瓶，可摄入的传感器），但其潜力在很大程度上仍然是出乎意料的。此外，移动应用程序（应用程序） 可以提供个性化的治疗监督，增加患者的自我管理并通过提供改善患者提供的沟通 患者支持和监测的更高级功能。但是，可用的与TB相关的应用并未集中在患者上 用户也没有得到充分评估。该提案以初步工作为基础1）将患者和专家的投入结合在一起 设计治疗支持应用程序的内容，功能和界面以及2）优化基于纸张的测试条以测试 在尿液中存在异念珠菌药物代谢产物，以直接监测依从性治疗。 TB-TST应用的现有版本具有 以下功能：它提供有关结核病及其治疗的教育，与护理协调员的沟通，跟踪治疗依从性（均由 自我报告和直接代谢物测试带图像），自我报告治疗副作用，并保留患者的“日记”注释。来自 此版本的试点测试将是这项拟议研究的起点。目的是：1）根据试点研究完善TB-TST干预措施 调查结果并应用以用户为中心的设计原则； 2）评估TB-TST对治疗结果的影响（成功，默认） 通常照顾； 3）评估患者和提供者对促进者的看法以及实施TB-TST和合成课程的障碍 与利益相关者和政策制定者一起学习。主要结果将是治疗成功。次要结果将包括：治疗默认 费率，自我报告的依从性，技术使用和可用性。发现不仅对结核病依从性，而且对疾病具有更大的影响 管理层更广泛，将提高我们对如何支持面临挑战治疗方案的患者的理解。

项目成果

Mobile Tuberculosis Treatment Support Tools to Increase Treatment Success in Patients with Tuberculosis in Argentina: Protocol for a Randomized Controlled Trial.

• DOI: 10.2196/28094
• 发表时间: 2021-06-21
• 期刊: JMIR research protocols
• 影响因子: 1.7
• 作者: Iribarren S;Milligan H;Goodwin K;Aguilar Vidrio OA;Chirico C;Telles H;Morelli D;Lutz B;Sprecher J;Rubinstein F
• 通讯作者: Rubinstein F

Patient-centered mobile tuberculosis treatment support tools (TB-TSTs) to improve treatment adherence: A pilot randomized controlled trial exploring feasibility, acceptability and refinement needs.

以患者为中心的移动结核病治疗支持工具（TB-TST），以提高治疗依从性：一项探索可行性、可接受性和改进需求的随机对照试验。

• DOI: 10.1016/j.lana.2022.100291
• 发表时间: 2022
• 期刊: Lancet regional health. Americas
• 作者: Iribarren,SarahJ;Milligan,Hannah;Chirico,Cristina;Goodwin,Kyle;Schnall,Rebecca;Telles,Hugo;Iannizzotto,Alejandra;Sanjurjo,Myrian;Lutz,BarryR;Pike,Kenneth;Rubinstein,Fernando;Rhodehamel,Marcus;Leon,Daniel;Keyes,Jesse;Demiris,
• 通讯作者: Demiris,